Apparatus and methods for performing mucosectomy

ABSTRACT

Apparatus and methods are provided for performing mucosectomy, such as to map out gastrointestinal surgery, including endoluminal gastric reduction. In one variation, the apparatus comprises a separating element and an integrated resection element. In one variation, the apparatus is configured to simultaneously separate mucosal tissue from underlying muscularis tissue and to resect the separated mucosal tissue. Methods of using the apparatus are provided.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a Continuation-In-Part application of co-pendingU.S. patent application Ser. No. 10/954,658 , filed Sep. 29, 2004, whichis a Continuation-In-Part application of co-pending U.S. patentapplication Ser. No. 10/797,910 , filed Mar. 9, 2004, both of which areincorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to methods and apparatus for performingmucosectomy. More particularly, the present invention relates to methodsand apparatus for mapping out gastrointestinal (“GI”) surgery, such asendoluminal gastric reduction, via mucosectomy.

Morbid obesity is a serious medical condition pervasive in the UnitedStates and other countries. Its complications include hypertension,diabetes, coronary artery disease, stroke, congestive heart failure,multiple orthopedic problems and pulmonary insufficiency with markedlydecreased life expectancy.

Several open surgical techniques have been developed to treat morbidobesity, e.g., bypassing an absorptive surface of the small intestine,or reducing the stomach size. These procedures are difficult to performin morbidly obese patients because it is often difficult to gain accessto the digestive organs. In particular, the layers of fat encountered inmorbidly obese patients make difficult direct exposure of the digestiveorgans with a wound retractor, and standard laparoscopic trocars may beof inadequate length. In addition, previously known open surgicalprocedures may present numerous life-threatening post-operativecomplications, and may cause atypical diarrhea, electrolytic imbalance,unpredictable weight loss and reflux of nutritious chyme proximal to thesite of the anastomosis.

Applicant has previously described methods and apparatus forlaparoscopically reducing a patient's stomach, for example, inco-pending U.S. patent application Ser. No. 10/8434,682, filed May 10,2004, which is incorporated herein by reference. Furthermore, Applicanthas previously described methods and apparatus for endoluminallyreducing a patient's stomach, for example, in co-pending U.S. patentapplication Ser. No. 10/735,030, filed Dec. 12, 2003, which also isincorporated herein by reference. Those applications describe techniquesfor creating a small pouch from within the patient's stomach that ispositioned below the gastroesophageal junction to limit food intake andpromote a feeling of satiety. The endoluminal pouch is expected to actin a manner similar to a Vertical Banded Gastroplasty (“VBG”).

The gastrointestinal lumen includes four tissue layers, wherein themucosa layer is the top (innermost) tissue layer, followed by connectivetissue, the muscularis layer and the serosa layer. One problem withendoluminal gastrointestinal reduction systems is that the anchors (orstaples) must engage at least the muscularis tissue layer in order toprovide a proper foundation, since the mucosa and connective tissuelayers tend to stretch elastically under the tensile loads imposed bynormal movement of the stomach wall during ingestion and processing offood. Applicant's previously-described techniques for stomach reductionaddress this concern by reconfiguring the stomach lumen via engagementof at least the muscularis layer of tissue.

It is expected that proper placement of anchors or suture to achievesuch stomach reduction will present significant challenges to a medicalpractitioner, due, for example, to the limited working space, as well asthe limited visualization provided by an endoscope or fiberscope. U.S.Pat. No. 6,558,400 to Deem et al. describes methods and apparatus formarking the interior of the stomach from the esophagus to the pylorus tomap out an endoluminal reduction procedure. Marking is achieved with dyechanneled through ports in a marking device or bougie. The bougieoptionally may comprise suction ports for evacuating the stomach aboutthe bougie, at which point the dye may be injected to stain the stomachalong points that contact the dye ports. The stomach then may beinsufflated for performing the endoscopic reduction procedure utilizingthe map provided by the dye marks stained onto the stomach mucosa.

A significant drawback of the marking technique described by Deem et al.is that dyes have a tendency to spread and are difficult to localize,especially in a fluid environment such as that which contacts the mucosalayer of the stomach. As such, it is expected that dye that does notpenetrate beyond the mucosa will provide an inaccurate and/or unstablemap for performing endoscopic gastric reduction. This, in turn, mayyield an incorrectly sized or poorly sealed stomach pouch, which mayrender the procedure ineffective in facilitating weight loss and/or mayresult in dangerous complications.

In view of the aforementioned limitations, it would be desirable toprovide methods and apparatus for mapping out endoluminalgastrointestinal surgery that may be readily localized, that enhanceaccuracy and stability of the surgical map, that facilitate directengagement of muscularis tissue from within the stomach and/or thatinitiate a wound healing response along approximated tissue.

BRIEF SUMMARY OF THE INVENTION

In view of the foregoing, the present invention provides apparatus andmethods for marking the interior of a patient's gastrointestinal lumen.In a first variation, the surgical map comprises localized RF scarringor mucosal ablation. In an alternative variation, the map comprisespegs, e.g. colored pegs, which may be biodegradable, e.g. fabricatedfrom polyglycolic acid. Alternatively, the pegs may comprise one or morecorkscrews advanced into tissue surrounding the GI lumen. In yet anotheralternative variation, the map comprises dye injected into at least thesubmucosa. The dye may be fluorescent or of varying colors.Alternatively, the dye may be disposed within nanospheres ormicrospheres implanted submucosally. In addition, or as an alternative,to dye spheres, the spheres may be magnetic, heat-able ferromagnetic orCurie point, plastic and inert, radiopaque, etc. As a still furtheralternative, the map may comprise the shaft of an endoluminal surgicaltool having specified dimensions and/or color-coding, etc. In anotheralternative variation, the map may be formed from surgical mesh.Additional mapping apparatus will be apparent.

In one preferred variation, placement of the map is accurately achievedusing suction ports and/or an inflatable member disposed along anendoluminal support, such as a shaft or other tool associated with theendoluminal GI surgery. When using suction, the stomach may be deflatedabout the support prior to deployment of the surgical map. When using aninflatable member, the inflatable member may be inflated to contacttissue prior to deployment of the map. As will be apparent, acombination of suction and inflation may be used to properly orienttissue prior to mapping.

In additional variations, mucosectomy and/or mucosal ablation isperformed to map out endoluminal GI surgery, to facilitate directendoluminal engagement of underlying muscularis tissue and/or toinitiate a wound healing response. Specialized apparatus may be providedto achieve desired spacing and/or positioning of tissue markings, andmay be provided to actually form the markings.

Methods of using apparatus of the present invention also are provided.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects and advantages of the present invention willbe apparent upon consideration of the following detailed description,taken in conjunction with the accompanying drawings, in which likereference characters refer to like parts throughout, and in which:

FIG. 1 is an isometric view of a first variation of apparatus of thepresent invention configured to map out an endoluminal gastrointestinalsurgery, the apparatus comprising suction ports and RF elementsconfigured to selectively scar or ablate the interior wall of the GIlumen;

FIGS. 2A-2C are, respectively, a side view, partially in section; across-sectional detail view along view line A-A in FIG. 2A; and aside-sectional view along view line B-B of FIG. 2A; illustrating amethod of using the apparatus of FIG. 1 to map out an endoscopic stomachreduction procedure;

FIG. 3 is a schematic view of an alternative variation of the apparatusof FIG. 1 that is configured to engage tissue via an inflatable member;

FIGS. 4A-4C are schematic views of alternative apparatus for mapping outan endoluminal GI surgery with pegs;

FIG. 5 is a schematic view of additional alternative apparatus formapping out an endoluminal GI surgery, the apparatus comprising acatheter configured to locally deliver a marking element at leastsubmucosally;

FIGS. 6A and 6B are, respectively, a side view and a side detail view,both partially in section, illustrating a method of using the apparatusof FIG. 5 to map out an endoluminal GI surgery;

FIGS. 7A-7D are, respectively, a side view, partially in section;side-sectional detail views along section line C-C in FIG. 7A; and aside-sectional view; illustrating a method of mapping out an endoluminalGI surgery with the shaft of an endoluminal surgical tool havingspecified characteristics;

FIGS. 8A-8C are, respectively, a side view, partially in section; across-sectional detail view along section line D-D in FIG. 8A; and aside-sectional view along section line E-E in FIG. 8A, illustrating amethod of mapping out endoluminal GI surgery with surgical mesh;

FIG. 9 is a side view, partially in section, illustrating a method ofmapping out endoluminal GI surgery with an RF marking element disposedon an inflatable member;

FIG. 10 is a schematic rear cut-away view, illustrating a method ofmapping out endoluminal GI surgery that facilitates alignment ofco-planar anterior and posterior tissue points;

FIGS. 11A and 11B are schematic detail views of tissue marking apparatusconfigured to pierce and coagulate tissue;

FIG. 12 is a detail schematic view illustrating a method of utilizingthe apparatus of FIG. 11 to mark tissue;

FIGS. 13A and 13B are schematic views of variations of the apparatus ofFIG. 11 comprising irrigation;

FIGS. 14A and 14B are schematic and schematic detail views ofmulti-point tissue marking apparatus configured to ablate and/or weldtissue;

FIG. 15 is schematic side-sectional view illustrating a method of usingthe apparatus of FIG. 14 to mark and weld tissue;

FIG. 16 is a schematic view illustrating a method of marking tissue withapparatus configured for plug mucosectomy and electrocautery;

FIG. 17 is a schematic side view of a variation of the apparatus of FIG.16 comprising irrigation;

FIG. 18 is a schematic view of another variation of the apparatus ofFIG. 16 comprising a cutting wire;

FIGS. 19A-19C are schematic views of variations of the apparatus of FIG.18 comprising depth-limiting elements;

FIGS. 20A-20H are a schematic rear cut-away view, a side-sectional view,detail schematic side sectional views and a detail schematic isometricsectional view, illustrating a method of using the apparatus of FIGS.16-19 to map out endoluminal GI surgery, to facilitate direct engagementof muscularis, and to perform endoluminal gastric reduction orpartition;

FIG. 21 is a schematic side view of a hemostasis catheter used incombination with the apparatus of 16-19;

FIGS. 22A-22D are schematic views of apparatus comprising removableand/or interchangeable/exchangeable heads for performing medicalprocedures;

FIGS. 23A and 23B are schematic side and side cut-away views,respectively, illustrating methods of using mucosectomy apparatuscomprising an actuable cutting wire to remove mucosal tissue;

FIGS. 24A and 24B are schematic views of a suction engagement variationof the apparatus of FIG. 23;

FIGS. 25A and 25B are schematic side views, illustrating a method ofusing a side-suction engagement variation of the apparatus of FIG. 23 toperform mucosectomy;

FIGS. 26A and 26B are, respectively, side cut-away and side views,partially in section, illustrating a method of performing mucosectomywith a rotating energizable wire variation of the apparatus of FIG. 23;

FIG. 27 is a schematic side view of energizable biopsy apparatuscomprising suction;

FIGS. 28-28C are schematic views illustrating variations of measuringapparatus configured for mapping out endoluminal GI surgery;

FIGS. 29A and 29B are, respectively, a schematic side view, partially insection, and a cross-sectional view along section line E-E of FIG. 29A,illustrating a laparoscopic endoluminal method of using anothervariation of the apparatus of FIG. 28 to map out endoluminal GI surgery;

FIGS. 30A and 30B are schematic side views, partially in section,illustrating a fully endoluminal method of using the apparatus of FIG.29 to map out endoluminal GI surgery;

FIGS. 31A and 31B are schematic views of combination measurement andmucosectomy apparatus shown, respectively, in a collapsed deliveryconfiguration and an expanded deployed configuration;

FIG. 32 is a schematic view of centerline marking apparatus;

FIGS. 33A and 33B are, respectively, a schematic side view, partially insection, and a schematic rear cut-away view, illustrating a method ofusing the apparatus of FIG. 32 to mark a centerline within a patient'sstomach for mapping out endoluminal GI surgery;

FIGS. 34A and 34B are schematic detail views illustrating a method ofusing a variation of the apparatus of FIG. 31 in combination with thecenterline markings of FIG. 33B to map out endoluminal GI surgery;

FIG. 35 is a schematic rear cut-away view illustration a method ofmapping out endoluminal GI surgery and facilitating direct muscularisengagement through plug mucosectomy, while promoting wound healingresponse post-surgery through strip mucosectomy;

FIGS. 36A and 36B are schematic views illustrating a method andapparatus for forming a strip mucosectomy from a series of plugmucosectomies; and

FIG. 37 is a schematic view of additional apparatus for forming a stripmucosectomy.

FIGS. 38A and 38B are schematic views of additional variations ofapparatus for performing mucosectomy.

FIGS. 39A and 39B are exploded and assembly views, respectively, ofanother variation of apparatus for performing tissue marking and/ormucosectomy.

FIGS. 40A and 40B are side views, partially in section, illustrating amethod of utilizing the apparatus of FIG. 39 to separate mucosal tissuefrom underlying muscularis tissue.

FIG. 41 is a schematic view illustrating a method of separating mucosaltissue from underlying muscularis tissue along a line.

FIG. 42 is a schematic view of integrated apparatus for separatingmucosal tissue from underlying muscularis tissue, and for resecting theseparated mucosal tissue.

FIGS. 43A-43C are schematic views illustrating a method of using theapparatus of FIG. 42 to resect mucosa.

FIG. 44 is a schematic view of a variation of the apparatus of FIG. 42.

FIG. 45 is a schematic view illustrating a method of using the apparatusof FIG. 44 to resect mucosa.

FIG. 46 is a schematic view of another variation of the apparatus ofFIG. 42.

FIG. 47 is a schematic view of yet another variation of integratedmucosal separation and resection apparatus.

FIG. 48 is a schematic view illustrating a method of using the apparatusof FIG. 47.

FIG. 49 is a schematic view of integrated mucosal separation andresection apparatus comprising a dissector.

FIGS. 50A and 50B are schematic views illustrating a method of using theapparatus of FIG. 49.

FIGS. 51A and 51B are, respectively, a schematic side view and aschematic detail view along section line A-A of FIG. 51A, of anothervariation of integrated mucosal separation and resection apparatus.

FIG. 52 is a schematic view illustrating a method of using the apparatusof FIG. 51.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to methods and apparatus for mapping outendoluminal gastrointestinal (“GI”) surgery. More particularly, thepresent invention relates to methods and apparatus for mapping outendoluminal gastric reduction.

Applicant has previously described methods and apparatus forendoluminally forming and securing GI tissue folds, for example, in U.S.patent application Ser. No. 10/735,030, filed Dec. 12, 2003, which hasbeen incorporated herein by reference. Such methods and apparatus may beused to reduce or partition the effective cross-sectional area of a GIlumen, e.g., to treat obesity by approximating the walls of the stomachto narrow the stomach lumen and/or create a pouch or endoluminalVertical Banded Gastroplasty (“VBG”), thus promoting a feeling ofsatiety and reducing the area for food absorption. However, as discussedpreviously, it is expected that proper placement of anchors or suture toform and secure such endoluminal VBG will present significant challengesto a medical practitioner, due, for example, to the limited workingspace, as well as the limited visualization provided by, e.g., anendoscope or fiberscope.

Referring now to FIG. 1, a first variation of apparatus for mapping outendoluminal GI surgery in accordance with the present invention isdescribed. Apparatus 10 comprises endoluminal support 12 having shaft 14with one or more, e.g., a plurality, of suction ports 16 and one ormore, e.g., a plurality, of radiofrequency (“RF”) marking electrodes 18disposed along the length of the shaft. Suction ports 16 are proximallycoupled to suction pump 20 via tubing 22. Likewise, each RF markingelectrode 18 is connected to switching station 30 via a wire 32. As seenin FIG. 1, wires 32 optionally may be routed through tubing 22 over atleast a portion of their length. Switching station 30 compriseselectrical contacts 34 that are electrically connected to RF markingelectrodes 18 via wires 32. Apparatus 10 further comprises RF generator40, which is configured to actuate electrodes 18 via switching station30. RF generator 40 comprises positive electrode 42 and negative orground electrode 44. RF generator 40 may comprise a commerciallyavailable RF generator, per se known, for example, such as thosedistributed by Everest Medical of Maple Grove, Minn.

In use, endoluminal support 12 may be endoluminally advanced within a GIlumen, e.g., a patient's stomach. Actuation of suction pump 20 fromoutside the patient draws suction through tubing 22 and suction ports16, thereby bringing luminal GI tissue into contact with shaft 14 ofendoluminal support 12. Meanwhile, negative electrode 44 of RF generator40 may be placed exterior to the patient, e.g., on the patient's chest,or on a metal operating table just under the patient's back while thepatient lies on the table. As will be apparent, negative electrode 44alternatively may be coupled to endoluminal support 12, for example,along shaft 14 at a location radially distant from RF electrodes 18.Positive electrode 42 may be selectively connected to any of theplurality of electrical contacts 34 of switching station 30, as desired,to actuate specified RF marking electrodes 18.

Actuation of electrodes 18 via RF generator 40 acts to locally burn,singe, cut, ablate, scar or otherwise injure tissue in contact with theelectrodes along shaft 14 of endoluminal support 12, thereby leavingidentifiable marks on the surface of the tissue that may be used to mapout an endoluminal GI surgery. As will be apparent to those of skill inthe art, the pattern of electrodes 18 and suction ports 16 about shaft14 of endoluminal support 12 may be altered as desired to facilitateformation of surgical maps having varying characteristics. Likewise, theshape or orientation of shaft 14 may be altered.

Switching station 30 facilitates actuation of individual electrodes 18,as well as actuation of any combination of the individual electrodes,including simultaneous actuation of all the electrodes. Such selectiveactuation is dependent upon which electrical contact(s) 34 are connectedto positive electrode 42 of RF generator 40 when the generator isenergized. As will be apparent, switching station 30 optionally may beomitted, and wires 32 may couple RF electrodes 18 directly to RFgenerator 40.

Endoluminal support 12 optionally may comprise one or more workinglumens (not shown) for advancing additional surgical instruments throughthe endoluminal support. Additionally or alternatively, endoluminalsupport 12 optionally may comprise proximal shaft 13 that is steerableand/or rigidizable or shape-lockable, e.g. via pull wires actuatedthrough handle 15. Rigidizable shafts are described, for example, inApplicant's co-pending U.S. patent application Ser. No. 10/735,030,filed Dec. 12, 2003, which has been incorporated herein by reference.When utilizing a steerable, rigidizable shaft, endoluminal support 12may be steered into proper position within a GI lumen, rigidized tomaintain its position, and then actuated as described above to marktissue and map out endoluminal GI surgery.

With reference now to FIG. 2, in conjunction with FIG. 1, a method ofusing the apparatus of FIG. 1 to map out an endoscopic stomach reductionprocedure is described. In FIG. 2A, endoluminal support 12 of apparatus10 is endoluminally advanced down a patient's throat into the patient'sstomach S. Suction ports 16 and RF electrodes 18 are oriented towardsthe greater curvature of stomach S. Negative electrode 44 of RFgenerator 40 is placed exterior to the patient in close proximity toshaft 14 of apparatus 10 (not shown). Suction pump 20 is then actuatedto pull suction through suction ports 16 and deflate the stomach aboutshaft 14 of endoluminal support 12, as in FIG. 2B. Positive electrode 42of RF generator 40 is connected to one or more electrical contacts 34 ofswitching station 30, and the RF generator is actuated to locally markthe interior wall of stomach S with marks M at locations in contact withactuated electrodes 18.

Once RF electrodes 18 have been actuated in a desired pattern and for adesired duration at a desired intensity, RF generator 40 is turned offand/or positive electrode 42 is disconnected from switching station 30.As seen in FIG. 2C, stomach S then may be insufflated, e.g., via airinjected through suction ports 16. Marks M burned or ablated into themucosa of the stomach may be used as a map for performing endoluminalstomach reduction, for example, as described in Applicant's co-pendingU.S. patent application Ser. No. 10/735,030.

Referring now to FIG. 3, an alternative variation of apparatus 10 isdescribed wherein the suction elements have been replaced withinflatable elements. Endoluminal support 12′ of apparatus 10′ comprisesinflatable member 50 coupled to shaft 14′. Inflatable member 50 isillustratively shown at least partially inflated in FIG. 3. RFelectrodes 18 are coupled to the exterior of the inflatable member in anappropriate pattern, and tubing 22 couples inflatable member 50 toinflation source 60, e.g., a compressor or a syringe. In FIG. 3,switching station 30 has been eliminated, and RF electrodes 18 have beenconnected directly to positive electrode 42 of RF generator 40 viawire(s) 32. In this manner, actuation of RF generator 40 energizes allelectrodes 18 simultaneously.

In use, endoluminal support 12′ is endoluminally advanced within apatient's stomach and/or GI lumen. Inflatable member 50 is inflated viainflation medium transferred from source 60 through tubing 22 to theinflatable member. The inflatable member conforms to the interiorprofile of the GI lumen, thereby bringing RF electrodes 18 into contactwith the interior wall of the lumen. The electrodes then may be actuatedas described previously to form marks M for mapping out an endoluminalGI surgery. As will be apparent, a combination of suction and inflationmay be used to properly orient tissue prior to marking and mapping.

Referring now to FIG. 4, alternative apparatus for mapping out anendoluminal GI surgery is described. As seen in FIG. 4A, apparatus 100comprises a plurality of pegs 110 that are configured to engage tissueand act as a map for endoluminal GI surgery. The pegs optionally maycomprise sharpened distal ends 112 configured to penetrate tissue. Pegs110 may also comprise optional barbs, hooks, etc. 113 to maintain thepegs in the tissue after penetration. The pegs may be endoluminallyimplanted at appropriate locations, then visualized to provide a map forthe GI surgery. They preferably are colored to enhance visibility, andoptionally may be provided in a variety of colors, shapes, sizes, etc.to provide additional mapping information. Pegs 110 preferably arebiodegradable, e.g., fabricated from polyglycolic acid. Pegs 110optionally may comprise a plurality of corkscrews 120. Corkscrews mayrequire less force to advance into tissue, as compared to pegs withsubstantially straight shafts having sharpened distal ends 112. Therotational motion used to advance corkscrews applies enhanced forcewithin the plane of tissue, as opposed to perpendicular to the plane. Asan alternative to corkscrews, screws 130 may be provided. Alternativelytacks 140 may be provided. Additional pegs will be apparent.

FIGS. 4B and 4C illustrate modified variations of previously describedapparatus 10 and 10′, respectively, that are configured to deliver anddeploy pegs 110 of apparatus 100. In FIG. 4B, apparatus 150 comprisesendoluminal support 152 having suction ports 156 disposed along shaft154. Suction ports 156 are coupled to suction pump 20 via tubing 22, asdescribed previously. Pegs 110 are disposed in channels 158 along shaft154 and may be deployed from the channels into tissue when tissue isdisposed about the shaft, e.g., via suction drawn through ports 156.Advancement of the pegs into tissue may be achieved via pushrods, e.g.torque-able pushrods (not shown). In FIG. 4B, a few pegs illustrativelyare shown advanced out of channels 158.

In FIG. 4C, apparatus 200 comprises endoluminal support 202 havinginflatable member 206 disposed along shaft 204. Pegs 110 are lightlyadhered to the surface of inflatable member 206, such that the pegs mayengage tissue and decouple from the inflatable member upon inflation ofthe inflatable member into contact with the tissue. Various mechanismsmay be provided for releasably securing pegs 110 to the surface ofinflatable member 206, for example, adhesives, electromagnets, fusemechanisms, etc.

With reference now to FIG. 5, alternative apparatus for mapping out anendoluminal GI surgery is described, the apparatus comprising a markingelement in combination with a catheter configured to locally deliver themarking element at least submucosally. Apparatus 300 comprisesendoluminal support 302 having suction ports 306 disposed along shaft304. Suction ports 306 are coupled to suction pump 20 via tubing 22, asdescribed previously. Apparatus 300 further comprises injection channels308 having retractable needles 310. Needles 310 are illustratively shownat least partially extended in FIG. 5.

In use, endoluminal support 302 may be advanced within a GI lumen withneedles 310 retracted. Suction then may be drawn through ports 306 tobring tissue into proximity with channels 308. Needles 310 then may beextended into the tissue to penetrate the tissue. When conductingendoluminal gastric procedures, the needles are configured to penetratethe tissue at least submucosally. Upon penetration of tissue by needles310, marking elements may be injected into the tissue below the surfacethrough the needles.

Illustrative subsurface or submucosal marking elements include, but arenot limited to, dyes, fluorescent dyes and colored dyes. As described inU.S. Pat. No. 6,558,400 to Deem et al., which is incorporated herein byreference, marking dyes may comprise, for example, methylene blue,thionine, acridine orange, acridine yellow, acriflavine, quinacrine andits derivatives, brilliant green, gentian violet, crystal violet,triphenyl methane, bis naphthalene, trypan blue, and trypan red. U.S.Pat. No. 6,558,400 describes using these dyes to mark or stain theinterior lining of the stomach. However, that reference does notdescribe injecting such dyes submucosally. Submucosal injection isexpected to enhance localization, stability and accuracy, as compared tomucosal staining. Additional dyes that may be utilized include black inkand India ink, as well as various combinations of dyes.

Additional subsurface/submucosal marking elements include, for example,saline or bulking agents, e.g. collagen, to achieve geometricmarking/mapping via localized protrusion of the mucosa. As yet anotheralternative, nanospheres or microspheres may be utilized, e.g. coloredspheres or dye-filled spheres. In addition, or as an alternative, to dyespheres, the spheres may be magnetic, heat-able ferromagnetic or Curiepoint, plastic and inert, bioresorbable, radiopaque, etc. Curie pointmaterials may be heated to a known temperature via an externalelectromagnetic field, for example, to cause local ablation,inflammation or scar formation, mucosectomy, etc. Such local marking maybe used to map out an endoluminal GI surgery.

With reference now to FIG. 6, a method of using the apparatus of FIG. 5to map out an endoluminal stomach reduction is described. In FIG. 6A,endoluminal support 302 of apparatus 300 is endoluminally advanced downa patient's throat into the patient's stomach S. Suction ports 306 andinjection channels 308, having needles 310 retracted therein, areoriented towards the greater curvature of stomach S. Suction pump 20 isactuated to pull suction through suction ports 306 and deflate thestomach about shaft 304 of endoluminal support 302. Needles 310 areadvanced out of injection channels 308 to penetrate tissue in proximityto the channels, as seen in FIG. 6B. The distal tips of needles 310 aredisposed submucosally. Marking elements 320, which may comprise dye,spheres, etc., are injected submucosally through needles 310, therebylocally and submucosally marking the interior wall of stomach S withmarks M at locations penetrated by the needles. Needles 310 are removedfrom the wall of stomach S, and suction pump 20 is deactivated, leavinga map of marks M within the wall of the stomach for endoluminal gastricreduction.

Referring now to FIG. 7, a method of mapping out an endoluminal gastricreduction with the shaft of an endoluminal surgical tool havingspecified dimensions and/or color-coding is described. Apparatus 400comprises surgical tool 402 having shaft 404 of specified dimensionsappropriate for forming an endoluminal VBG, for example, a diameter ofabout 1 cm. Shaft 404 optionally may also comprise a plurality ofvariously colored or patterned sections to provide additional mappinginstructions or guideposts for a medical practitioner. In FIG. 7, shaft404 illustratively comprises first and second sections 406 a and 406 bhaving different surface patterns.

In FIG. 7A, shaft 404 is disposed in stomach S inferior to the patient'sgastroesophageal junction GE. In FIG. 7B, anterior An and posterior Potissue ridges are formed on either side of shaft 404, for example,utilizing apparatus and methods described in Applicant's co-pending U.S.patent application Ser. No. 10/735,030, which is incorporated herein byreference. The ridges are then wrapped around shaft 404 and secured toone another, as in FIG. 7C. In FIG. 7D, removal of shaft 404 leavespouch P in stomach S, thereby completing endoluminal VBG. Apparatus 400maps out the endoluminal VBG procedure by providing the medicalpractitioner with visual cues as to proper location for formation of theanterior and posterior ridges, as well as proper sizing for pouch P uponapproximation of the ridges.

With reference to FIG. 8, a method of using surgical mesh to map outendoluminal GI surgery is described. In FIG. 8, apparatus 150 and pegs110 of FIG. 4 are used in conjunction with surgical mesh strips 500,which are coupled to pegs 110 disposed in channels 158. As seen in FIG.8A, endoluminal support 152 of apparatus 150 is advanced into apatient's stomach S. Suction is then drawn through ports 156 via pump20, such that the stomach deflates about shaft 154 of device 152, asseen in FIG. 8B. Pegs 110 are advanced out of channels 158 into the wallof the stomach, thereby tacking surgical mesh strips 500 to the wall. Asseen in FIG. 8C, suction is deactivated and apparatus 150 is removedfrom the patient, leaving strips 500 as a surgical map disposed on theanterior and posterior of stomach S. The strips may be used to map outthe formation of ridges and a pouch in a manner similar to thatdescribed with respect to FIG. 7.

With reference to FIG. 9, a method of mapping out endoluminal gastricreduction or restriction with an RF marking electrode disposed on aninflatable member is described. In FIG. 9, apparatus 600 comprisesendoluminal support 605 having inflatable member 610 with positive RFmarking electrode 620 disposed in a ring about the surface of theballoon. Ring electrode 320 preferably is flexible and ‘painted’ on theexterior of inflatable member 610, for example, with a conductive paint,such as a silver paint. In this manner, electrode 620 may accommodatechanges in dimension as inflatable member 610 is inflated or deflated.

Inflatable member 610 is coupled to an inflation source, such aspreviously described inflation source 60 of FIG. 3, for inflating anddeflating the member. Furthermore, RF marking electrode 620 iselectrically connected to an RF generator, such as RF generator 40 ofFIG. 3, which further is coupled to a negative electrode, e.g. electrode44 of FIG. 3, that preferably is disposed external to the patient.Suction elements also may be provided, for example, suction ports 16 incommunication with suction pump 20, as in FIG. 1.

In FIG. 9, endoluminal support 605 of apparatus 600 has been advancedendoluminally through esophagus E into stomach S. Inflatable member 610then has been inflated, e.g. via inflation source 60, with a known fluidvolume. Endoluminal support 605 has been retracted proximally untilinflatable member 610 abuts gastroesophageal junction GE.

Ring electrode 620 then is activated, e.g. via RF generator 40, tolocally singe, burn or otherwise mark the interior of stomach S. Aftermarking, electrode 620 is deactivated, inflatable member 610 isdeflated, and endoluminal support 605 of apparatus 600 is removed fromstomach S, thereby leaving a map within the stomach for conductingendoluminal gastric reduction or restriction. Advantageously, the volumeof fluid disposed in upper left portion 612 of inflatable member 610(the portion of the inflatable member disposed proximal of markingelectrode 620) during activation of electrode 620 substantially definesthe mapped out volume of a pouch that may be formed utilizing the mapprovided by apparatus 600. In this manner, a stomach pouch of specifiedvolume may be accurately formed. As will be apparent, prior to markingstomach S via activation of electrode 620, the stomach optionally may bedeflated, e.g., via suction, in order to better approximate stomachtissue against inflatable member 610 and electrode 620.

Referring now to FIG. 10, a method of mapping out endoluminal GI surgerythat facilitates alignment of co-planar anterior and posterior tissuepoints is described. As seen in FIG. 10, two rows of marks M may beformed to mark the posterior Po and anterior An positions for tissueapproximation to form, e.g., a pouch within a patient's stomach S. MarksM, which may be formed utilizing any of the techniques describedpreviously or via any other technique, illustratively comprisealternating single marks M₁ and double marks M₂. During approximation ofposterior and anterior tissue to form a tissue pouch, e.g., duringformation and approximation of posterior and anterior tissue foldsaround bougie 750 advanced through esophagus E into stomach S, marks M₁and M₂ may provide a medical practitioner with visual indicators forproper placement of tissue anchors and/or suture. Furthermore, thealternating pattern of the marks may reduce a risk of inadvertentlyapproximating posterior and anterior tissue segments disposed indifferent planes. Like properly buttoning a shirt, the marks may ensurethat the right ‘buttons’ and ‘holes’ are aligned, i.e. that co-planaranterior and posterior tissue points are approximated, rather thanopposing tissue points that are out of plane. Marks M₁ and M₂ maycomprise any variety of shapes, e.g., circles, ellipses, etc., which aresuitable for the purposes described above. Moreover, any number of marksalong a single row, e.g., anterior An, may be utilized in a variety ofpatterns provided that the marks along the opposing row, e.g., posteriorPo, are complementary so that marks M₁ and M₂ may be appropriatelyaligned and approximated.

With reference to FIG. 11, variations of tissue marking apparatusconfigured to pierce and coagulate tissue are described. In FIG. 11A,apparatus 700 comprises piercing element 702 extending from coagulatortip 704. Both tip 704 and element 702 may be energizable, eitherseparately or in combination, in order to locally cut, ablate, scar,burn, singe, coagulate, or otherwise injure tissue with which they comeinto contact. The tip and/or piercing element may, for example, beenergized via RF generator 40. Optionally, tip 704 and element 702 maycomprise a bipolar electrode pair. Alternatively, each may be monopolaror may individually comprise bipolar elements. FIG. 11B illustrates analternative variation of apparatus 700 having alternative piercingelement 702′ that is wider that element 702 of FIG. 11A. The distal endof element 702′ is sharpened to facilitate tissue piercing and may berotated while disposed within coagulated tissue, e.g., to slough off orotherwise remove coagulated/ablated tissue.

Referring now to FIG. 12, a method of utilizing the apparatus of FIG. 11to mark tissue is described. As shown, tissue T may comprise cut Cformed by piercing element 702 or 702′, as well as coagulated (orablated, etc.) region Co formed with coagulator tip 704. A depth of cutC may be controlled by specifying a length of element 702/702′ thatextends beyond coagulator tip 704. The cut and/or the coagulated regionmay provide a physical marking that may be visualized for mapping out asurgical procedure. Coagulation Co is expected to reduce bleedinginduced by formation of cut C and may also facilitate engagement of thecoagulated tissue, as described hereinafter.

In addition to providing a physical marking, when tissue T comprisesstomach tissue, cut C may locally remove mucosa and cause bleeding. Ifcut C is held in apposition with other tissue, the local bleeding ormucosectomy may initiate a wound healing response that gradually fusesthe cut to the apposed tissue. Applicant has previously describedinitiation of a wound healing response to fuse tissue, for example, inco-pending U.S. patent application Ser. No. 10/898,683, filed Jul. 23,2004, which is incorporated herein by reference in its entirety.Furthermore, local removal of the mucosa along cut C or coagulationregion Co may expose underlying muscularis, which then may be engageddirectly.

With reference to FIG. 13, additional variations of tissue markingapparatus configured to pierce and coagulate, as well as irrigate,tissue are described. In FIG. 13A, apparatus 710 comprises double bladepiercing element 712, which optionally may be energizable, that extendsfrom energizable coagulation tip 714 having irrigation ports 715. FIG.13B illustrates a variation of apparatus 710 having single bladepiercing element 712′.

Tip 714 is coupled to torqueable shaft 716 having irrigation lumen 717that is connected to ports 715. Fluid irrigants may be injected throughlumen 717 of shaft 716 and ports 715 of tip 714. Shaft 716 also conveyselectromagnetic impulses between energy source 720 (which may, forexample, comprise RF generator 40) and tip 714 or piercing element712/712′. In use, element 712/712′ may pierce tissue, tip 714 maycoagulate tissue, and irrigation ports 715 may convey irrigants forcooling pierced and/or coagulated tissue. Furthermore, shaft 716 may betorqued while piercing element 712/712′ is disposed within tissue; inthis manner, tissue singed, burned, coagulated, etc., with tip 714 maybe removed.

With reference to FIG. 14, multi-point tissue marking apparatusconfigured to ablate and/or weld tissue is described. As seen in FIG.14A, apparatus 730 comprises shaft 732 coupled to energy source 720 andhaving tip 734 with multiple elongate elements 736. As seen in thedetail view of FIG. 14B, each element 736 comprises energizable core 737surrounded by insulated sleeve 738. Sleeve 738 extends near the distalend of each element 736, such that core 737 is only exposed for ablatingor welding tissue, etc., at the distal tip of the element.

Referring to FIG. 15, a method of using apparatus 730 to mark and weldtissue is described. Mucosal tissue layer Muc and muscularis tissuelayer Mus of stomach tissue T have been welded together within weld zoneW. Such welding may be achieved, for example, with an elongate element736. The exposed distal core of such an element may be placed in contactwith tissue in the weld zone and energized to weld the mucosal tissue tothe muscularis tissue. As apparatus 730 comprises multiple elements 736,this procedure may be repeated at several points simultaneously.

Malleable submucosal connective tissue, which weakly joins muscularistissue to mucosal tissue; as well as the composition of mucosal tissueitself, may make it challenging to securely engage muscularis tissuefrom the interior of a patient's stomach. Thus, in addition to providingtissue marks that may be used to map out a surgical procedure, use ofapparatus 730 may facilitate engagement of tissue within the weldzone(s). Such engagement may be achieved due to more secure binding ofthe mucosal layer to the muscularis layer, as well as denaturing ordenuding of the mucosal layer.

With reference now to FIG. 16, a method of marking tissue with apparatusconfigured for plug mucosectomy and electrocautery is described.Apparatus 800 comprises shaft 802 having lumen 803 and sharpened distaltip 804. Shaft 802 illustratively comprises knob 806 for rotating theshaft; however, shaft 802 alternatively or additionally may be rotatedvia a motor (not shown). The shaft is proximally disposed within hollowhandle 808 through distal port 809 a. Handle 808 further comprisesproximal port 809 b, which is coupled to suction pump 20 via tubing 22,and O-ring 810, which may facilitate rotation of shaft 802 and whichprovides a seal for drawing suction through lumen 803 of the shaft.

Handle 808 also comprises floating electrical connection 812 coupled toelectrical jack 814, which is connected to energy source 720, e.g., RFgenerator 40. Connection 812 contacts shaft 802 and facilitatesenergizing of the shaft during concurrent rotation thereof, e.g., viaknob 806. Shaft 802 comprises insulation sleeve 816 that covers theshaft between the point of contact with electrical connection 812 andthe sharpened distal tip 804. In this manner, distal tip 802 may beenergized selectively via energy source 720.

As seen in FIG. 16, sharpened distal tip 804 may be advanced againsttissue T, and suction may be drawn through lumen 803 of shaft 802, suchthat the sharpened distal tip pierces the tissue and is advancedtherein. Shaft 802 may be rotated via knob 806, and tip 804 may beenergized, such that plug mucosectomy PM is formed and cauterized withintissue T. Plug mucosectomy PM marks the tissue and may be used to mapout a surgical procedure. Furthermore, removal of the mucosa Muc mayfacilitate grasping or other engagement of the underlying muscularisMus, and also may facilitate optional initiation of a wound healingresponse through apposition of plug mucosectomy PM with other tissue.

Referring to FIG. 17, a variation of apparatus 800 is describedcomprising optional irrigation. In FIG. 17, handle 808′ comprises ports809 b(1) and 809 b(2). Port 809 b(1) may, for example, be coupled tosuction pump 20 via tubing 22, as described previously, while port 809b(2) may be coupled to an irrigation source for injecting fluids throughlumen 803 of shaft 802. In this manner, apparatus 800 may provide forboth energizing and delivery of fluids at the position of plugmucosectomy.

Referring to FIG. 18, another variation of apparatus 800 is describedcomprising cutting wire 818, which optionally may be energizable. Wire818 is used in combination with distal tip 804 to form a plugmucosectomy. The wire severs the mucosal tissue layer from themuscularis tissue layer during rotation of shaft 802 for formation ofthe plug mucosectomy. The wire may also ablate or coagulate tissue whileenergized. Wire 818 optionally may be energized alone or concurrentlywith tip 804 (e.g., as part of a bipolar electrode pair), and optionallymay be energized while suction is drawn and/or irrigants are injectedthrough lumen 803 of shaft 802.

With reference now to FIG. 19, further variations of apparatus 800 aredescribed comprising depth-limiting elements. The depth-limitingelements optionally may be energized and utilized in combination withtip 804 to form a bipolar electrode pair. In FIG. 19A, apparatus 800comprises expandable mesh 830. Mesh 830 is distally coupled to shaft 802and is proximally coupled to tube 840. Tube 840 is coaxially disposedabout shaft 802 and may be advanced relative to the shaft to expand themesh, as shown. In the expanded configuration, mesh 830 may contacttissue to limit a depth of tissue cutting. Mesh 830 also may becollapsed to a lower profile delivery and retrieval configuration byretracting tube 840 relative to shaft 802.

In FIG. 19B, apparatus 800 comprises expandable bellows 832 that isdistally coupled to shaft 802 and proximally coupled to tube 840. Aswith mesh 830, bellows 832 may be expanded and collapsed via movement oftube 840 relative to shaft 802. FIG. 19C illustrates another variationof apparatus 800 comprising inflatable balloon 834 disposed near distaltip 804 of shaft 802. Balloon 834 may be inflated to contact tissue andlimit a depth of tissue cutting. As with the previous variations,suction and/or irrigation may be provided in combination with FIG. 19.

Referring to FIG. 20, a method of using apparatus 800 to map outendoluminal GI surgery, as well as to directly engage muscularis tissueand to actually perform endoluminal gastric reduction or partition, isdescribed. Apparatus 800 may be advanced, e.g., endoluminally,laparoscopically, etc., into stomach S, and a plurality of plugmucosectomies PM may be formed along opposing anterior An and posteriorPo rows within the stomach, as in FIG. 20A. The opposing rows provide amedical practitioner with a map for performing an endoluminal gastricrestriction procedure. For example, an anterior plug mucosectomy may beengaged for forming a tissue fold, and a co-planar posterior plugmucosectomy may be engaged to form an opposing tissue fold that may beapproximated with the anterior tissue fold to form a localized partitionof the stomach. This procedure may be repeated, concurrently orsequentially, until anterior and posterior tissue folds have beenbrought into apposition along the opposing rows of plug mucosectomies,thereby partitioning the patient's stomach, e.g., forming a pouchtherein, as described hereinbelow. The map provided by plugmucosectomies PM may guide formation of the tissue folds to ensureproper placement, spacing, etc., of the folds

Advantageously, plug mucosectomies PM may facilitate direct internalengagement of gastric muscularis tissue. In FIG. 20B, corkscrewengagement element 900 illustratively has been advanced through tissuefolding and securing apparatus 910, and into a plug mucosectomy fordirect internal engagement of the muscularis. It is expected that directengagement of muscularis (e.g., engagement of muscularis withoutencountering intervening mucosa, or engagement through welded or ablatedmucosa) will reduce a length, size and/or required working space ofapparatus for internally engaging, folding and securing gastric tissue.Exemplary variations of such engaging, folding and securing apparatus,including methods of use, are described in Applicant's co-pending U.S.patent application Ser. No. 10/955,245, filed Sep. 29, 2004, which isincorporated herein by reference in its entirety.

FIGS. 20C-20F are detail views of element 900 and apparatus 910illustrating direct muscularis engagement, as well as formation andapproximation of opposing tissue folds. As seen in FIG. 20C, corkscrewengagement element 900 has been advanced within posterior Po plugmucosectomy PM, and has directly engaged muscularis tissue Mus. In FIG.20D, element 900 is retracted relative to tissue folding apparatus 910,thereby drawing stomach tissue T between first bail 912 and second bail914 of apparatus 910, and forming posterior tissue fold F_(p). As seenin FIG. 20E, launch tube 916 of apparatus 910 may be reconfigured from alow profile delivery configuration to a deployment configurationsubstantially perpendicular to tissue fold F_(p). Needle 918 they may beadvanced through tube 916 and across the tissue fold. As seen in FIG.20F, securing element 920 may be deployed through needle 918 fortemporarily or permanently maintaining the tissue fold. This proceduremay be repeated to form opposing anterior tissue fold F_(a), and theanterior and posterior tissue folds may be approximated to locallypartition a patient's stomach.

Concurrently or sequentially (or both), opposing rows of anterior R_(a)and posterior R_(p) tissue folds may be formed along the opposinganterior and posterior rows of plug mucosectomies PM of FIG. 20A, asseen in FIG. 20G. As seen in FIG. 20H, the opposing rows may beapproximated, either during formation of individual opposing folds orafter formation of opposing rows of folds (or both), to form pouch orpartition P within stomach S. The rows of opposing tissue folds may beapproximated and secured together in a variety of ways, e.g., viasecuring elements or suture. Alternatively, the rows may be clamped(temporarily or otherwise) or held against one another for welding thetissue together. Various tissue clamping devices have been describedpreviously which have been utilized for various purposes, for example,U.S. SIR No. H2037 to Yates et al. and U.S. Pat. No. 5,300,065 toAnderson, both of which are incorporated herein by reference in theirentireties, describe in further detail clamping tools that may be usedfor welding or sealing tissue.

As seen in FIG. 20H, illustrative bipolar clamping and welding tool 930may be utilized to approximate and/or secure the rows of opposing foldstogether. Tool 930 comprises first electrode 933 disposed on first clamp932 and second electrode 935 disposed on second clamp 934. Tool 930 may,for example, be positioned such that the anterior R_(a) and posteriorR_(p) rows of tissue folds are clamped between first clamp 932 andsecond clamp 934. Radiofrequency or other energy then may be deliveredacross first electrode 933 and second electrode 935 to weld the anteriorand posterior rows of tissue folds together. Optionally, solder So maybe provided along the region of overlap or contact between theapproximated rows of tissue folds in order to facilitate tissue welding.A variety of tissue solders, per se known, may be utilized, e.g.,albumin.

Referring now to FIG. 21, apparatus 800 may be used in combination withmonopolar, bipolar or multipolar hemostasis catheter 950 advancedthrough lumen 803 of shaft 802. When utilized in combination withcatheter 950, plug mucosectomy optionally may be performed ‘hot’ or‘cold’ (i.e. with or without energizing distal tip 804), and distal tip804, as well as shaft 802, of apparatus 800 optionally may beelectrically insulated. Catheter 950 may be advanced within a plugmucosectomy site and energized to cauterize the site. Optional irrigantsI may be injected through the catheter to cool the site during or afterelectrocautery.

With reference to FIG. 22, interchangeable marking apparatus isdescribed. Apparatus 1000 comprises shaft 1002 having female screw 1004for attaching and removing interchangeable/exchangeable heads to shaft1002 for performing various medical procedures. In FIG. 22A, apparatus1000 further comprises illustrative head 1010 having mating male screw1012 for mating with female screw 1004 of shaft 1002. As will beapparent, head 1010 alternatively may comprise the female screw andshaft 1002 may comprise the male screw. Furthermore, any alternativemating elements may be provided. Head 1010 illustratively comprises thedistal region of apparatus 730 of FIG. 14A. As with apparatus 730, theelongate elements of head 1010 may be energized to ablate tissue.

In FIG. 22B, alternative head 1020 is described comprising mating screw1022 and the distal region of apparatus 700 of FIG. 11B. FIG. 22Cillustrates head 1030 with mating screw 1032 and the cutting elementdistal region of apparatus 710 of FIG. 13A. In FIG. 22D, head 1040 withmating screw 1042 comprises the distal region of plug mucosectomyapparatus 800 of FIG. 16. Additional exchangeable heads will beapparent.

Referring now to FIG. 23, methods of using additional variations ofmucosectomy apparatus to remove mucosal tissue are described. In FIG.23A, apparatus 1100 comprises tube 1110 having lumen 1111 through whichgrasper 1120, illustratively corkscrew engagement element 900 that maybe screwed into tissue to reversibly engage the tissue, has beenadvanced. Apparatus 1100 further comprises wire 1130 coupled to thedistal end of tube 1110 and configured to pivot thereabout, e.g., viacontrollable actuation by a medical practitioner external to the patient(see, e.g., FIG. 24).

As shown, grasper 1120 engages and separates mucosal tissue Muc frommuscularis tissue Mus. A plug of the engaged mucosal tissue is retractedproximal of wire 1130, which is then pivoted about tube 1110 to severand separate the plug of tissue from the mucosa, thereby exposing theunderlying muscularis, e.g., for the purposes of physical marking, easeof tissue engagement and/or wound healing. Severed tissue optionally maybe aspirated or otherwise removed from the patient.

Wire 1130 may comprise a sharpened blade to sever the tissue.Alternatively or additionally, wire 1130 may be electrically coupled toenergy source 720 and may be energized to cut through the tissue. To actas a safety mechanism, energizing and pivoting of wire 1130 may belinked, such that wire 1130 is only energized when a medicalpractitioner pivots the wire.

FIG. 23B provides a variation of apparatus 1100 that illustrates anexemplary technique for removing severed tissue from the patient. InFIG. 23B, “Archimedes” screw pump 1140 is disposed within lumen 1111 oftube 1110. Rotation of screw pump 1140 proximally conveys materialdisposed within the screw. Thus, severed tissue may be retracted withintube 1110, e.g., via suction or via grasper 1120 (which illustrativelyis coaxially disposed within a central lumen of the screw pump). Screwpump 1140 then may be rotated to remove the severed material and/orproximally retract the material far enough within lumen 1111 to makeroom for additional plugs of severed mucosa removed at additionaldesired locations. Screw pump 1140 optionally may be integrated withcorkscrew engagement element 900. Flexible medical devices incorporatingscrew pumps have previously been described in U.S. Pat. No. 6,156,046 toPassafaro et al., which is incorporated herein by reference in itsentirety.

Referring now to FIG. 24, a suction engagement variation of apparatus1100 is described that does not comprise grasper 1120 or screw pump1140. Rather, suction may be drawn through lumen 1111 of tube 1110 toengage mucosal tissue, as well as to aspirate tissue severed via wire1130. A diameter of lumen 1111 may be specified to facilitate engagementof mucosal tissue, but not muscularis tissue.

FIG. 24 also illustrate an exemplary technique for pivoting wire 1130about tube 1110. As shown, wire 1130 may be distally disposed withinrotational bearing 1112 of tube 1110, and may be proximally coupled toelongated member 1132. Elongated member 1132 extends proximally out ofthe patient from wire 1130 through lumen 1111 of tube 1110. A medicalpractitioner may advance member 1132 relative to tube 1110 in order topivot wire 1130 about bearing 1112 and tube 1110. With member 1132proximally retracted, wire 1130 may be disposed in the deliveryconfiguration of FIG. 24A, while with member 1132 distally extended,wire 1130 may pivot to the deployed tissue-cutting configuration of FIG.24B.

When wire 1130 is energizable, electrical or other energy impulses maybe transmitted from energy source 720 to wire 1130 through elongatedmember 1132. Member 1132 optionally may be insulated to protect themedical practitioner from, e.g., electrical discharge. Furthermore,distal advancement of member 1132 optionally may activate energy source720 while proximal retraction of the member may deactivate the energysource.

Referring to FIG. 25, another suction variation of apparatus 1100 isdescribed. In FIG. 25, tube 1110 has been modified, such that lumen 1111terminates at side aperture 1114 instead of a distal opening.Furthermore, wire 1130 has been formed into a cutting loop that may beadvanced and retracted within lumen 1111 via elongated member(s) 1132.

As seen in FIG. 25A, wire 1130 may be advanced distally of side aperture1114, which may be positioned in proximity to mucosal tissue Muc.Suction then may be drawn through lumen 1111 of tube 1110 to separate aplug of the mucosal tissue from muscularis Mus, with only submucosaltissue Sub disposed therebetween. As seen in FIG. 25B, retracting wirecutting loop 1130 relative to tube 1110 severs the plug of mucosaltissue disposed within lumen 1111. As discussed previously, wire 1130may be sharpened and/or energized to sever the tissue plug. The severedtissue is then aspirated via suction drawn through lumen 1111. Thisprocedure may be repeated at additional locations, e.g., to map out a GIprocedure, to facilitate direct engagement of the muscularis, toinitiate a wound healing response, etc.

With reference to FIG. 26, yet another suction variation of apparatus1100 is described. In FIG. 26, lumen 1111 again terminates at a distalopening of tube 1110. Wire 1130 has been formed into an arc coupled toelongated member 1132. Member 1132 is configured for rotation and torquetransmission. As seen in FIG. 26A, suction may be drawn through tube1110 to draw a plug of muscularis Mus within lumen 1111. Wire 1130contacts the plug of tissue and may be rotated via member 1132 to severthe plug, as seen in FIG. 26B. Member 1132 optionally may be coupled toa motor (not shown) to facilitate rotation. Alternatively, a medicalpractitioner may manually rotate the member. Wire 1130 may be sharpenedand/or energized in order to sever the tissue plug, which then isaspirated via suction drawn through lumen 1111.

Referring now to FIG. 27, additional mucosectomy apparatus is described.Apparatus 1200 comprises biopsy probe 1210, which has been advancedthrough lumen 1221 of tube 1220. Probe 1210 comprises aspiration holes1212. In use, probe 1210 may be advanced against muscularis tissue, andthe jaws of the probe may be closed to sever a plug of the tissue.Suction then may be drawn through lumen 1221 of tube 1220, with holes1212 providing for airflow through probe 1210. This facilitatesaspiration of severed mucosal tissue disposed within the probe. Probe1210 optionally may be energizable, e.g., via coupling to energy source720. If energized, probe 1210 preferably is only energized along edge1215 of jaws 1214, thereby enhancing energy density for a givenmagnitude of energy input.

With reference to FIG. 28, measuring apparatus are described fordetermining appropriate spacing of tissue markings, e.g., anterior andposterior tissue markings for mapping out endoluminal gastric reductionor partitioning. In FIGS. 28A and 28B, a variation of measuringapparatus 1300 illustratively comprises elongated shaft 1302, anteriorruler 1304 and posterior ruler 1306. The rulers and shaft optionally maybe flexible to facilitate endoluminal delivery. Rulers 1304 and 1306comprise measurement indicia In for measuring distances along therulers. The rulers are coupled to shaft 1302 of apparatus 1300 at radialbearing 1303 and are configured to rotate about the bearing from thecollapsed delivery configuration of FIG. 28A to the expanded deployedconfiguration of FIG. 28B.

Rulers 1304 and 1306 may also comprise energizable electrodes 1308 a and1308 b, which may be energized via energy source 720 in order to marktissue. A distance D between electrodes 1308 a and 1308 b in theexpanded deployed configuration of FIG. 28B may be specified to providea desired spacing of tissue markings formed therewith. For example, theelectrodes may be spaced such that the spacing between opposing anteriorand posterior tissue markings is as desired. As will be apparent, asingle electrode or more than two electrodes alternatively may beprovided. Furthermore, alternative marking elements may be provided,e.g., ink injection elements, etc.

FIG. 28C provides another variation of apparatus 1300, illustrativelydisposed in deployed configuration. In the variation of FIG. 28C,apparatus 1300 comprises unitary ruler 1304′ rotationally coupled toshaft 1302 at bearing 1303. As with rulers 1304 and 1306, ruler 1304′comprises measurement indicia In and optional electrode or other markingelement 1308, illustratively coupled to energy source 720. Ruler 1304′may be cantilevered from a reduced profile delivery and/or retrievalposition in line with a longitudinal axis of shaft 1302, to a positionout of line with the shaft's longitudinal axis (as in FIG. 28C) fortaking measurements and/or marking tissue. Shaft 1302 of apparatus 1300may be rotated about its longitudinal axis to measure distances withruler 1304′ in any direction perpendicular to the shaft.

Referring now to FIG. 29, a laparoscopic endoluminal method of usinganother variation of apparatus 1300 to map out endoluminal GI surgery isdescribed. In FIG. 29, bougie 750 has been advanced endoluminally down apatient's throat into the patient's stomach S, and has been positionedalong the lesser curvature of the patient's stomach. A variation ofapparatus 1300 has been laparoscopically advanced into the patient'sstomach in a collapsed delivery configuration, then expanded to thedeployed configuration and brought into contact with bougie 750, as seenin FIG. 29A.

As best seen in FIG. 29B, apparatus 1300 may comprise central member1305 that stabilizes apparatus 1300 against bougie 750 (bougie 750alternatively may comprise a groove or other surface feature in whichapparatus 1300 may be mated, stabilized, etc.). Rulers 1304 and 1306extend from shaft 1302 towards the anterior An and posterior Po regionsof stomach S, respectively. As shown, the rulers may comprise acurvature and/or may be formed from a self-conforming material, such asNitinol. In this manner, the rulers may approximately follow thecurvature of stomach S, thereby providing for more accurate measurementsof distance with indicia In.

With rulers 1304 and 1306 properly positioned, optional electrodes 1308may be energized to physically mark the tissue with markings M.Alternatively, secondary marking apparatus may be utilized to mark thetissue at desired locations, determined, for example, via indicia In.Apparatus 1300 then may be repositioned along the length of bougie 750in additional planes, where additional anterior and posterior tissuemarkings may be formed until a desired pattern of markings has beenachieved, e.g., opposing anterior and posterior rows of markings. Theapparatus then may be collapsed back to the delivery configuration andremoved from the patient. Bougie 750 optionally may also be removed.

With reference to FIG. 30, a fully endoluminal method of using apparatus1300 to map out endoluminal GI surgery is described. In FIG. 30A,steerable endoluminal support 1400 is advanced per-orally into thepatient's stomach, and is then retroflexed such that a distal opening oflumen(s) 1401 that extends through the support is positioned facing body1402 of the support. Steerable endoluminal supports capable ofretroflexing are described in more detail in Applicant's co-pending U.S.patent application Ser. No. 10/797,485, filed Mar. 9, 2004, which isincorporated herein by reference in its entirety (not shown).

Apparatus 1300 is then advanced through lumen 1401, is expanded to thedeployed configuration, and is positioned in contact with body 1402 ofsupport 1400, as in FIG. 30B. In another variation, apparatus 1300 maybe attached to a distal region of support 1400. Rulers 1304 and 1306contact the patient's stomach S along anterior and posterior segments,respectively. Tissue markings may be made, e.g., with electrodes 1308.Then, a degree of retroflexion of endoluminal support 1400 may bealtered to reposition apparatus 1300 in a different plane within thepatient's stomach wherein additional tissue markings may be made. Theprocedure may be repeated until a desired pattern of tissue markingshave been made for mapping out GI surgery. Apparatus 1300 then may becollapsed back to the delivery configuration within lumen 1401 and maybe removed from the patient.

Referring now to FIG. 31, combination measurement and mucosectomyapparatus is described. Apparatus 1500 comprises central shaft 1501 withoptional central member 1502 having end region 1503 for stabilizing theapparatus against, e.g., bougie 750. Apparatus 1500 further comprisescollapsible anterior and posterior shafts 1504 and 1506, respectively,that extend from shaft 1501. Shafts 1504 and 1506 illustrativelycomprise optional indicia In for measuring distances within a bodylumen, as well as plug mucosectomy tips 1505 and 1507, respectively.Tips 1505 and 1507 are similar to previously described sharpened distaltip 804 of apparatus 800 and are configured to form plug mucosectomieswithin a patient's stomach. The tips optionally may be energized toablate, cut or cauterize tissue. FIG. 31A illustrates a collapseddelivery and/or retrieval configuration of apparatus 1500, while FIG.31B illustrates an expanded deployed configuration.

In use, tips 1505 and 1507 may, for example, be utilized tosimultaneously or sequentially form anterior and posterior plugmucosectomies within a patient's stomach. In addition or as analternative to tips 1505 and 1507, shafts 1504 and 1506 may comprise anypreviously described or other engagement, marking, ablation,mucosectomy, etc., tips for mapping out or otherwise facilitatingendoluminal GI surgery, e.g., for facilitating direct muscularisengagement and/or for initiating a wound healing response. Furthermore,the shafts may comprise tips that perform different functions. Forexample, one shaft may comprise a grasper for engaging and stabilizingapparatus 1500 against tissue, while the opposing shaft may compriseapparatus for marking tissue or performing mucosectomy. Additionalvariations will be apparent.

With reference to FIG. 32, in combination with FIG. 33, centerlinemarking apparatus 1600 is described. Apparatus 1600 comprisesendoluminal support 1602, which may, for example, comprise a bougie or asteerable and/or shape-lockable shaft. Support 1602 comprises aplurality of electrodes 1604 disposed at specified positions withdesired spacing along the support. Electrodes 1602 are electricallycoupled to energy source 720 to facilitate selective energizing of theelectrodes to mark tissue in contact therewith. Support 1602 furtheroptionally may comprise inflatable member 1610 for reversibly engaging apatient's pylorus, as well as measurement indicia In and lumen 1603 withport or slot 1620 in communication with the lumen.

As seen in FIG. 33A, endoluminal support 1602 of apparatus 1600 may bepositioned within a patient's stomach S, e.g., along a lesser curvatureof the stomach. In one variation, support 1602 may be shape-locked tomaintain its position along the lesser curvature. Additionally oralternatively, optional inflatable member 1610 may be positioned withinthe patient's pylorus P and inflated to reversibly engage the pylorus.Electrodes 1602 then may be energized to form centerline markings C, asseen in FIG. 33B. The centerline markings may provide a reference fromwhich anterior and posterior distances may be measured or determined,and may facilitate partitioning of a patient's stomach, e.g., viaformation of anterior and posterior tissue markings and/or tissue folds.

Referring again to FIG. 33A, endoscope E or other instruments optionallymay be advanced through lumen 1603 and slot 1620 while endoluminalsupport 1602 is disposed within the patient's stomach. Endoscope E may,for example, provide visual confirmation that support 1602 is properlypositioned for formation of centerline markings C. Methods and apparatusfor performing gastroplasty with slotted endoluminal supports aredescribed in greater detail in Applicant's co-pending U.S. patentapplication Ser. No. 10/841,415, filed May 7, 2004, which isincorporated herein by reference in its entirety.

With reference to FIG. 34, a method of using the apparatus of FIG. 31 incombination with the centerline markings of FIG. 33 to map outendoluminal GI surgery is described. As seen in FIG. 34A, a variation ofapparatus 1500 is provided comprising central member 1502 with anoptional engagement element end region 1503′, illustratively a corkscrewgrasping element, for engaging a centerline marking C. The positioningof central member 1503 in contact with the centerline orients apparatus1500 within the patient's stomach. As seen in FIG. 34B, anterior An andposterior Po plug mucosectomies PM may be formed with tips 1505 and 1507of shafts 1504 and 1506. Apparatus 1500 then may be repositioned alongthe centerline as shown, e.g., into contact with additional centerlinemarkings C to form additional plug mucosectomies. The spacing of suchmarkings may be specified to facilitate mapping out of endoluminal GIsurgeries.

Referring now to FIG. 35, a method of mapping out endoluminal GI surgeryand facilitating direct muscularis engagement through plug mucosectomy,while initiating a wound healing response post-surgery through stripmucosectomy, is described. Centerline markings C may be formed withinstomach S, and then opposing rows of anterior An and posterior Pomarkings may be formed utilizing markings C as a reference, e.g.,opposing rows of plug mucosectomies PM may be formed. The anterior andposterior mucosectomies may provide a map of locations whereat a medicalpractitioner may engage the stomach for forming tissue folds.Furthermore, plug mucosectomies PM advantageously facilitate directengagement of muscularis tissue, as described previously.

In addition to the plug mucosectomies, opposing anterior and posteriorstrip mucosectomies SM may be formed between the plug mucosectomies andthe centerline markings. A medical practitioner may internally engagethe patient's stomach at a plug mucosectomy PM to form a tissue fold,such that the plug mucosectomy is positioned at the top of the fold(i.e., the turning point or critical point of the fold, where the slopeof the fold changes direction), and a strip mucosectomy SM forms a sideof the fold. Opposing anterior and posterior folds may be formed in thismanner and approximated to bring the opposing strip mucosectomies SMinto contact. The approximated folds may be secured together in order topartition stomach S and to initiate a wound healing response along theapposed strip mucosectomies SM that in time may fuse them together.

With reference to FIG. 36, a method of forming a strip mucosectomy froma series of plug mucosectomies is described. As seen in FIG. 36A, spacedrows of plug mucosectomies PM may be formed within a patient's stomachS. Hook knife 1700 comprising cutting element 1702, which optionally maybe energizable, may be positioned within a plug mucosectomy PM and drawndown to cut away mucosa Muc disposed between the plug mucosectomies,thereby forming line mucosectomy LM. As seen in FIG. 36B, opposing linemucosectomies may be formed along the opposing rows of plugmucosectomies. Then, strip mucosectomy SM may be formed by removingmucosal tissue Muc disposed between the opposing line mucosectomies LM,e.g., by grasping the mucosal tissue and pulling it off, therebyexposing underlying muscularis Mus.

Referring to FIG. 37, additional apparatus for forming a line or stripmucosectomy is described. Apparatus 1800 comprises shaft 1802 coupled tohandle 1804 and having articulating and energizable distal region 1803.Distal region 1803 may, for example, be articulated by actuation oflever 1805 disposed along handle 1804. Distal region 1803 is coupled toenergy source 720 for selectively energizing the region. Region 1803 maybe positioned against GI tissue at a desired location and energized toablate and/or remove the mucosa, thereby forming a strip or linemucosectomy. Articulation of region 1803 may facilitate positioning ofthe region in contact with tissue along its length.

With reference to FIG. 38, additional variations of apparatus forperforming mucosectomy are described. As seen in FIG. 38A, apparatus1900 illustratively comprises shaft 1910 having first lumen 1911 a andsecond lumen 1911 b. Optional suction tube 1920 has been advancedthrough lumen 1911 a, while optional ligation snare tube 1930 has beenadvanced through lumen 1911 b. Ligation snare 1940 has been advancedthrough tube 1930 against mucosal tissue Muc. Snare 1940 may, forexample, be fabricated from a shape memory material, e.g., Nitinol, suchthat the snare may resiliently assume a pre-formed bend or other shapeto lie adjacent to the mucosal tissue upon exiting tube 1930.Furthermore, the snare may be energizable.

Once properly positioned, suction may be drawn through tube 1920 tocapture a plug of mucosal tissue within snare 1940. The snare then maybe retracted to cut, sever, ligate, etc., the plug of mucosal tissuedisposed therein, thereby facilitating direct engagement of muscularisMus, mapping of gastrointestinal surgery and/or initiation of a woundhealing response. This procedure optionally may be achieved withoututilizing tubes 1920 and 1930. In such a variation, suction may be drawndirectly through lumen 1911 a, and ligating snare 1940 may be advanceddirectly through lumen 1911 b.

FIG. 38B illustrates a variation of apparatus 1900 wherein ligationsnare tube 1930 is pivotably connected to optional support 1950 thatextends from the distal region of shaft 1910. Advancement of tube 1930relative to the shaft and the support may provide tube 1930 with acurvature that facilitates proper placement of snare device 1940′against mucosal tissue Muc. As shown, snare device 1940′ does notcomprise a pre-formed bend and may be advanced through tube 1930 whilethe tube is disposed parallel to the mucosa.

Referring now to FIG. 39, another variation of apparatus for performingtissue marking and/or mucosectomy is described. As seen in FIG. 39A,apparatus 2000 comprises syringe 2010, needle 2020 and overtube 2030.Needle 2020 comprises syringe attachment 2022 and overtube attachment2024. Overtube 2030 having lumen 2031 may comprise, for example, asubstantially rigid laparoscopy trocar or, alternatively, a flexibleendoluminal overtube. As seen in FIG. 39B, needle 2020 may be coupled tosyringe 2010 via syringe attachment 2022 and may be advanced throughlumen 2031 of overtube 2030. Additionally, needle 2020 optionally may becoupled to overtube 2030 via overtube attachment 2024.

With reference to FIG. 40, a method of utilizing the apparatus of FIG.39 to separate mucosal tissue from underlying muscularis tissue isdescribed. As seen in FIG. 40A, the sharpened distal tip of needle 2020may be advanced into submucosa Sub between mucosa Muc and muscularisMus. A distance that needle 2020 extends beyond a distal end of overtube2030 may act as a depth-limiting element to ensure that the needle isnot inadvertently advanced into the muscularis. As seen in FIG. 40B, afluid, such as air, saline, dye, etc., may be injected through syringe2010 and needle 2020 into the submucosal space to form fluid bolus Bothat separates mucosa Muc from muscularis Mus. Bolus Bo may provide avisually identifiable tissue marking and/or may facilitate mucosectomy,e.g., via a snare device.

Referring now to FIG. 41, needle 2020 may be repositioned to additionallocations in order to separate the muscularis and mucosal tissue at aplurality of desired locations and/or in any desired shape orconfiguration. In FIG. 41, illustrative strip bolus SB is formed byforming a plurality of boluses along a line. This may facilitateoptional formation of a strip or line mucosectomy.

With reference to FIG. 42, integrated apparatus for both separatingmucosal tissue from underlying muscularis tissue, and for resecting theseparated mucosal tissue, is described. Apparatus 2100 compriseselongated shaft 2110, which may be rigid or flexible and configured forlaparoscopic or endoluminal advancement. Distal needle 2120 extends fromshaft 2110 and is configured to separate mucosal tissue from muscularisvia injection of a bolus of fluid, as described previously with respectto needle 2020 of FIGS. 39-41. Lumen 2111 extends through shaft 2110 andis in fluid communication with needle 2120 for delivery of the fluidbolus. The distal end of needle 2120 may project from shaft 2110 at asufficient distance such that needle 2120 may be inserted unhinderedthrough or into the mucosa Muc.

Shaft 2110 further comprises channel 2130 which may define a curvedchannel and may extend proximally to provide sufficient spacing forparting the resected mucosa Muc. Dimension D across the channel limits adepth of mucosal resection, thereby reducing a risk of resectingunderlying muscularis or serosal tissue. Energizable element 2140, whichmay comprise a wire or conductive segment, may extend across channel2130 for resecting mucosa. Element 2140 is proximally connected, e.g.,via wire(s) 2142, to an energy source, such as previously describedenergy source 720, which may, for example, comprise previously describedRF generator 40, although any alternative energy source may be provided.Although element 2140 is illustrated as a wire, element 2140 mayalternatively be a blade having a cutting edge for slicing through themucosa.

Referring now to FIG. 43, a method of using apparatus 2100 to separateand resect mucosal tissue is described. As seen in FIG. 43A, needle 2120pierces mucosal tissue Muc and is disposed within submucosa Sub orwithin the mucosal tissue itself. Fluid bolus Bo is injected through theneedle into the submucosal space to separate the mucosa from muscularisMus. The amount of fluid injected may be dispensed at a steady rate orit may be injected intermittently to provide for measured dispensationof the fluid. In FIG. 43B, as apparatus 2100 is advanced distally,channel 2130 limits a depth of insertion of needle 2120, and energizableelement 2140 abuts the separated mucosa. The energizable element isenergized to resect the mucosa along channel 2130. As seen in FIG. 43C,needle 2120 may continue to inject fluid bolus Bo as apparatus 2100 isadvanced, thereby forming a line or strip of separated mucosa Muc thatis resected away with energizable element 2140.

With reference to FIG. 44, a variation of the integrated mucosalseparation and resection apparatus of FIG. 42 is described. Shaft 2110′of apparatus 2100′ comprises hook 2112 that directs needle 2120 towardthe proximal end of apparatus 2100′ and forms channel 2130′. Energizableelement 2140, which is coupled to an energy source, extends acrosschannel 2130′ for resecting mucosal tissue. Element 2140 additionally oralternatively may comprise a mechanical cutting blade. Dimension D′across channel 2130′ limits a depth of mucosal resection and reduces arisk of muscularis or serosal tissue resection.

FIG. 45 illustrates a method of using the apparatus of FIG. 44.Apparatus 2100′ may be used in a manner similar to apparatus 2100,except that resection is achieved while proximally retracting apparatus2100′, as opposed to distally advancing the apparatus. As shown, needle2120 is retracted into submucosa Sub, and fluid bolus Bo is injectedthrough the needle to separate mucosa Muc from muscularis Mus. Asapparatus 2100′ is retracted, needle 2120 optionally may continue toinject fluid into the submucosal space. Element 2140 is energized, andthe element resects the separated mucosa along a line or strip. Channel2130′ limits the depth of mucosal resection.

With reference to FIG. 46, additional variations of the apparatus ofFIG. 42 are described. It is expected that apparatus 2100″ may beespecially well suited for laparoscopic and/or endoluminal use, thoughit should be understood that it alternatively or additionally may beused in a pure endoluminal fashion or in any other manner. As seen inFIG. 46, needle 2120 is disposed at an angle with respect to shaft2110″. The angle between needle 2120 and shaft 2110″ may be varied asdesired or necessary. In the variation of FIG. 46A, energizable element2140 extends across channel 2130″ parallel to the longitudinal axis ofshaft 2110″. In the variation of FIG. 46B, the energizable elementextends across the channel at an angle, illustratively perpendicular, tothe longitudinal axis of the shaft. The variations of FIG. 46 may beused in a manner similar to that described previously with respect toapparatus 2100 or 2100′. For example, needle 2120 may be inserted intothe submucosal space to inject a bolus of fluid that separates themucosa from the muscularis. Energizable element 2140 then may be used toresect the separated mucosa.

Referring now to FIG. 47, yet another variation of integrated mucosalseparation and resection apparatus is described. Apparatus 2200comprises shaft 2210 having inclined surface or wedge 2220 withsharpened distal tip 2222. Wedge 2220, which optionally may comprise aneedle configured to inject fluids, illustratively is disposedperpendicular to the longitudinal axis of shaft 2210; however, it shouldbe understood that the wedge alternatively may be positioned at anyother desired angle or orientation relative to the shaft and/or to blade2230. If a needle is utilized with wedge 2220, one or more openings ofthe needle for fluid dispensation may be located at the distal tip 2222(as a hollow puncture needle) or along the sides of the length of wedge2220. Blade 2230 having sharpened edge 2232 is positioned in proximityto the wedge and forms channel 2240. As illustrated by arrows in FIG.47, the position of blade 2230 relative to wedge 2220 optionally may bealtered to adjust the size of channel 2240. Edge 2232 of blade 2230optionally may be energizable.

With reference to FIG. 48, a method of using apparatus 2200 to performmucosectomy is described. Sharpened distal tip 2222 pierces mucosa Mucand is positioned in the submucosal space Sub. As shaft 2210 is movedlaterally, the mucosa moves up the inclined surface of wedge 2220 and isseparated from muscularis Mus. If wedge 2220 comprises a needle, a bolusof fluid optionally may be injected into the submucosa to facilitateseparation of the mucosa from the muscularis.

Upon reaching a desired separation from the muscularis, the mucosacontacts blade 2230 and is resected by sharpened edge 2232 of the blade.Edge 2232 optionally may be energized to facilitate such resection.Continued lateral movement of shaft 2210 resects mucosa Muc along a lineor strip.

Referring now to FIG. 49, integrated mucosal separation and resectionapparatus comprising a dissector is described. Apparatus 2300 compriseselongated shaft 2310 having end dissector 2320. Dissector 2320 comprisessharpened distal tip 2322 having needle 2324, e.g., for injecting fluidsubmucosally. Dissector 2320 further comprises actuable jaws 2326 forresecting mucosa. Jaws 2326 may be energizable and coupled to an energysource.

With reference to FIG. 50, a method of using apparatus 2300 isdescribed. As seen in FIG. 50A, needle 2324 is advanced into submucosalspace Sub, and fluid bolus Bo is injected through the needle into thespace to separate mucosa Muc from muscularis Mus. The arrow in FIG. 50Aillustrates that apparatus 2300 optionally may be rotated relative tothe tissue, as desired. In FIG. 50B, apparatus 2300 illustratively hasbeen rotated about 90° relative to the tissue to properly align jaws2326 for engaging the tissue.

As seen in FIG. 50B, apparatus 2300 is withdrawn to remove needle 2324and the distal portion of jaws 2326 from the submucosal space. Jaws 2326then are opened for engaging and resecting the separated mucosa. Thejaws preferably are energized as they engage mucosa Muc, which dissectsor resects the mucosa as the jaws are closed about the tissue.Alternatively or additionally, the jaws may be sharpened to resect thetissue. This process of separating the mucosa from the muscularis,followed by resection of the mucosa, may be repeated as desired.

Referring now to FIG. 51, another variation of integrated mucosalseparation and resection apparatus is described. Apparatus 2400comprises inclined member 2410, which may, for example, comprise awedge, an inclined plane or a ‘shoe horn’-type device. Member 2410comprises raised resection element 2420, which may, for example,comprise a blade or other cutting element or an energizable element,such as an RF wire. When element 2420 comprises an energizable element,member 2410 optionally may be fabricated from a material of low electricconductivity, such as a ceramic.

FIG. 52 illustrates a method of using apparatus 2400. An incision orpuncture is formed through mucosa Muc, and member 2410 is advancedthrough the incision/puncture into submucosal space Sub. Apparatus 2400optionally may form the initial incision through mucosa Muc throughwhich member 2410 enters submucosal space Sub. For example, the distalend of member 2410 may comprise a sharpened element for piercing themucosa. Alternatively, the distal end of the member may be energizableto ablate a hole through the mucosa. Additional techniques for enteringthe submucosal space will be apparent.

Once disposed within the submucosal space, continued advancement ofmember 2410 urges the mucosa up the member's inclined surface, therebyseparating the mucosa from muscularis Mus. Once separated, the mucosaautomatically contacts resection element 2420 and is resected by theelement, for example, via a cutting force or via RF ablation. Member2410 may be advanced along any desired path to resect mucosa along thepath.

Although preferred illustrative embodiments of the present invention aredescribed hereinabove, it will be apparent to those skilled in the artthat various changes and modifications may be made thereto withoutdeparting from the invention. For example, a variety of energy sourcesoptionally may be utilized to mark, resect or otherwise manipulatetissue, including, but not limited to lasers (pulsed or continuous), RF(monopolar, bipolar or multipolar), high energy ultrasound, etc. It isintended in the appended claims to cover all such changes andmodifications that fall within the true spirit and scope of theinvention.

1. A method for resecting mucosal tissue from an interior of a patient'sstomach, the method comprising simultaneously separating the mucosaltissue from underlying muscularis tissue and resecting the separatedmucosal tissue along an anterior segment of the patient's stomach;simultaneously separating the mucosal tissue from underlying muscularistissue and resecting the separated mucosal tissue along a posteriorsegment of the patient's stomach, said posterior segment opposing saidanterior segment; forming opposing tissue folds along the opposinganterior and posterior segments; and approximating the opposing tissuefolds to partition the patient's stomach.
 2. The method of claim 1,wherein resecting mucosal tissue further comprises resecting the mucosaltissue at desired locations to form physical markings for mapping outendoluminal gastrointestinal surgery.
 3. The method of claim 1, whereinresecting mucosal tissue further comprises cutting the mucosal tissue.4. The method of claim 1, wherein resecting mucosal tissue furthercomprises ablating the mucosal tissue.
 5. The method of claim 1 furthercomprising aspirating the resected mucosal tissue from the patient'sstomach.
 6. The method of claim 1 further comprising cauterizing mucosaltissue adjacent to the resected mucosal tissue to stanch bleeding. 7.The method of claim 1 further comprising engaging exposed muscularistissue underlying the resected mucosal tissue.
 8. The method of claim 1further comprising initiating a wound healing response along one or morepoints of contact between the approximated opposing tissue folds.
 9. Themethod of claim 1 further comprising welding the approximated opposingtissue folds together along one or more points of contact between theapproximated folds.
 10. The method of claim 1, wherein separating themucosal tissue from underlying muscularis tissue further comprisesinjecting a bolus of fluid into a submucosal space between the mucosaltissue and the underlying muscularis tissue.
 11. The method of claim 1,wherein separating the mucosal tissue from underlying muscularis tissuefurther comprises urging the mucosal tissue along an inclined surfacedisposed in a submucosal space between the mucosal tissue and theunderlying muscularis tissue.
 12. The method of claim 1, whereinsimultaneously separating and resecting the mucosal tissue furthercomprises providing integrated apparatus configured to simultaneouslyseparate and resect the mucosal tissue.
 13. The method of claim 12,wherein providing integrated apparatus further comprises providingintegrated apparatus comprising a separating element and a resectionelement.
 14. The method of claim 13, wherein providing integratedapparatus comprising a separating element further comprises providing aseparating element chosen from the group consisting of wedges, inclinedplanes, inclined surfaces, shoe horns, needles, fluid boluses,dissectors, and jaw members.
 15. The method of claim 13, whereinproviding integrated apparatus comprising a resection element furthercomprises providing a resection element chosen from the group consistingof energizable elements, RF elements, wires, cutting elements, blades,dissectors, and jaw members.
 16. The method of claim 1, whereinresecting the separated mucosal tissue further comprises automaticallyengaging the mucosal tissue upon separation of the mucosal tissue fromthe underlying muscularis tissue.